Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

All,
We'd like to engage a second supplier to develop one of our key starting materials that is currently under patent by another supplier.  The samples would be used for development uses only (non-commercial and non-clinical) until patent expiry.  Does this infringe upon the patent owner rights?  Any references on this topic?

Thank you

35 U.S.C. 271 Infringement of patent.
(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

You should ask your company's patent attorney for a definitive answer, but I hope this helps. I'd also suggest reading the remainder of 35USC271.



------------------------------
Thomas Hoegh
Edina MN
United States
------------------------------

Original Message:
Sent: 26-Feb-2021 15:39
From: Anonymous Member
Subject: Using patented compounds during development

This message was posted by a user wishing to remain anonymous

All,
We'd like to engage a second supplier to develop one of our key starting materials that is currently under patent by another supplier.  The samples would be used for development uses only (non-commercial and non-clinical) until patent expiry.  Does this infringe upon the patent owner rights?  Any references on this topic?

Thank you

The courts have ruled years ago that performing development work or testing does NOT infringe patent rights.  Patents only protect someone from its commercial use.  Development work and testing is not considered commercial use.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 28-Feb-2021 11:59
From: Thomas Hoegh
Subject: Using patented compounds during development

35 U.S.C. 271 Infringement of patent.
(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

You should ask your company's patent attorney for a definitive answer, but I hope this helps. I'd also suggest reading the remainder of 35USC271.



------------------------------
Thomas Hoegh
Edina MN
United States

Original Message:
Sent: 26-Feb-2021 15:39
From: Anonymous Member
Subject: Using patented compounds during development

This message was posted by a user wishing to remain anonymous

All,
We'd like to engage a second supplier to develop one of our key starting materials that is currently under patent by another supplier.  The samples would be used for development uses only (non-commercial and non-clinical) until patent expiry.  Does this infringe upon the patent owner rights?  Any references on this topic?

Thank you

"The court ruled that whenever experiments were performed for business purposes, those experiments were not exempt."
Russo, A.A. and Johnson, J., 2015. Research use exemptions to patent infringement for drug discovery and development in the United States. Cold Spring Harbor perspectives in medicine, 5(2), p.a020933.

This seems like a pretty good paper on the subject which outlines two categories of exemptions to "use" infringement. The category which exempts 'experimentation' or development is pretty narrow as it excludes work done for a business purpose.

Interesting question and discussion.

------------------------------
Thomas Hoegh
Edina MN
United States
------------------------------

Original Message:
Sent: 01-Mar-2021 09:52
From: Michael Hamrell
Subject: Using patented compounds during development

The courts have ruled years ago that performing development work or testing does NOT infringe patent rights.  Patents only protect someone from its commercial use.  Development work and testing is not considered commercial use.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 28-Feb-2021 11:59
From: Thomas Hoegh
Subject: Using patented compounds during development

35 U.S.C. 271 Infringement of patent.
(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

You should ask your company's patent attorney for a definitive answer, but I hope this helps. I'd also suggest reading the remainder of 35USC271.



------------------------------
Thomas Hoegh
Edina MN
United States

Original Message:
Sent: 26-Feb-2021 15:39
From: Anonymous Member
Subject: Using patented compounds during development

This message was posted by a user wishing to remain anonymous

All,
We'd like to engage a second supplier to develop one of our key starting materials that is currently under patent by another supplier.  The samples would be used for development uses only (non-commercial and non-clinical) until patent expiry.  Does this infringe upon the patent owner rights?  Any references on this topic?

Thank you

According to the article cited, this is true in general.

However, the FDA's Waxman-Hatch Act and subsequent court cases (Bolar v. Roche) created a 'safe harbor' provision for 'drug' development activities, including biologics and devices.  As such, most development and testing activities in the FDA area are exempt from normal patent infringement claims.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States
------------------------------

Original Message:
Sent: 01-Mar-2021 13:54
From: Thomas Hoegh
Subject: Using patented compounds during development

"The court ruled that whenever experiments were performed for business purposes, those experiments were not exempt."
Russo, A.A. and Johnson, J., 2015. Research use exemptions to patent infringement for drug discovery and development in the United States. Cold Spring Harbor perspectives in medicine, 5(2), p.a020933.

This seems like a pretty good paper on the subject which outlines two categories of exemptions to "use" infringement. The category which exempts 'experimentation' or development is pretty narrow as it excludes work done for a business purpose.

Interesting question and discussion.

------------------------------
Thomas Hoegh
Edina MN
United States

Original Message:
Sent: 01-Mar-2021 09:52
From: Michael Hamrell
Subject: Using patented compounds during development

The courts have ruled years ago that performing development work or testing does NOT infringe patent rights.  Patents only protect someone from its commercial use.  Development work and testing is not considered commercial use.

------------------------------
Michael Hamrell, Ph.D., RAC, FRAPS
Huntington Beach CA
United States

Original Message:
Sent: 28-Feb-2021 11:59
From: Thomas Hoegh
Subject: Using patented compounds during development

35 U.S.C. 271 Infringement of patent.
(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

You should ask your company's patent attorney for a definitive answer, but I hope this helps. I'd also suggest reading the remainder of 35USC271.



------------------------------
Thomas Hoegh
Edina MN
United States

Original Message:
Sent: 26-Feb-2021 15:39
From: Anonymous Member
Subject: Using patented compounds during development

This message was posted by a user wishing to remain anonymous

All,
We'd like to engage a second supplier to develop one of our key starting materials that is currently under patent by another supplier.  The samples would be used for development uses only (non-commercial and non-clinical) until patent expiry.  Does this infringe upon the patent owner rights?  Any references on this topic?

Thank you

Apologies to Anonymous If I hijacked your question!

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 28-Feb-2021 11:59
From: Thomas Hoegh
Subject: Using patented compounds during development

35 U.S.C. 271 Infringement of patent.
(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.
(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

You should ask your company's patent attorney for a definitive answer, but I hope this helps. I'd also suggest reading the remainder of 35USC271.



------------------------------
Thomas Hoegh
Edina MN
United States

Original Message:
Sent: 26-Feb-2021 15:39
From: Anonymous Member
Subject: Using patented compounds during development

This message was posted by a user wishing to remain anonymous

All,
We'd like to engage a second supplier to develop one of our key starting materials that is currently under patent by another supplier.  The samples would be used for development uses only (non-commercial and non-clinical) until patent expiry.  Does this infringe upon the patent owner rights?  Any references on this topic?

Thank you

Gentlemen:

Good points and lot of learning! May I direct you both (Hoegh & Hamrell) to comment on the question raised specifically regarding the a chemical considered as a starting material for an ultimate API (drug substance) used for finished drug product development?
Based on what I am learning is that one could start development and testing (per Waxman-Hatch) prior to patent expiry using a patented API and drug product dosage form for an approved indication but the above question is specific to a chemical that is considered a starting material for an ultimate API.

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 26-Feb-2021 15:39
From: Anonymous Member
Subject: Using patented compounds during development

This message was posted by a user wishing to remain anonymous

All,
We'd like to engage a second supplier to develop one of our key starting materials that is currently under patent by another supplier.  The samples would be used for development uses only (non-commercial and non-clinical) until patent expiry.  Does this infringe upon the patent owner rights?  Any references on this topic?

Thank you